By Samuel E. Pondrom, JD, ByrdAdatto

Over the past several years, the U.S. Food and Drug Administration (FDA) has approved various medications intended to help individuals with type-2 diabetes control their blood sugar. The most recent of these medications is Ozempic, a drug that has gone viral amongst celebrities and social media influencers for the drug’s purported miracle weight loss effects.

Ozempic FDA Approval

Ozempic is an injectable semaglutide-based medication. In 2017, the FDA originally approved Ozempic for treating type-2 diabetes. The drug works by mimicking glucagon-like peptide-1 (GLP-1), a hormone involved in appetite and eating, and helps stimulate insulin secretion in a glucose dependent manner. Essentially, Ozempic helps individuals feel fuller for longer after meals and regulates how one’s body uses sugar and stores fat, leading to weight loss.

Use of Ozempic in Aesthetics

Ozempic is not technically a weight loss drug. However, a study sponsored by Novo Nordisk, the manufacturer of Ozempic, has found that taking the drug can induce weight loss. Ozempic affects weight in two main ways: (1) it affects the hypothalamus in the brain, reducing hunger and appetite; and (2) it slows the rate of stomach emptying, leading to prolonged fullness after meals.

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Additional Semaglutide Information

For more information on using semaglutides in a medical spa practice, including podcasts, blog posts and links to FDA resources, visit AmSpa's semaglutide resource page.

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Compliance Considerations to Prescribe Ozempic in a Medical Practice

Despite its FDA approval for type-2 diabetes, many physicians have prescribed Ozempic for weight loss purposes. This practice is technically “off-label” use. The FDA does not regulate off-label use, and it is not uncommon for physicians to prescribe medications for an off-label purpose. Once a drug is approved by the FDA, physicians may prescribe a drug for an unapproved use if they believe it is medically appropriate for their patient. Regardless, a health care provider should always discuss using an approved drug for an unapproved use with their patient before prescribing the medication, and they should receive proper written consent from their patient.

Telemedicine

Some medical practices have begun to prescribe Ozempic via telemedicine. Although telemedicine is a convenient way to consult patients, health care providers must make sure they comply with their state’s telemedicine laws before incorporating it into their practice. It is important to remember that the standard of care does not change in telemedicine—physicians will be held to the same standard of care as they would be if they were conducting an in-person consultation. This means that physicians will still need to establish the proper physician-patient relationship and conduct an initial assessment. Dozens of telemedicine websites have popped up allowing individuals to receive a prescription for Ozempic without ever seeing a doctor; the process typically requires a person to fill out a form, talk to a physician over the phone, and then pick up the prescription. One company that is capitalizing on the use of telemedicine is WW (formerly Weight Watchers). The company recently announced that it acquired Sequence—a company that allows customers to schedule telehealth appointments with doctors who will prescribe drugs for weight loss, such as Ozempic.

Many state telemedicine laws require physicians to see a patient over video and go through an initial consultation before prescribing any medication. Prescribing medication to a patient without proper guidance can also lead to further health complications later, especially if there is no appropriate follow-up. If a practice plans to utilize telemedicine for purposes of prescribing Ozempic, it becomes imperative for them to check the state telemedicine laws.

Downsides of Ozempic

One issue with Ozempic is that it is not a quick and easy fix for weight loss. Ozempic is intended for long-term use, meaning that once someone who has been taking the drug suddenly stops taking it, they will likely start to gain back the weight they have lost.

Another unintended side effect of taking Ozempic is a phenomenon known as “Ozempic Face.” Dr. Paul Jarrod Frank, a dermatologist in New York, coined the term to describe the way the face can lose volume or cave in as a result of Ozempic.

Impacts of Ozempic Popularity

The FDA recently announced a shortage of Ozempic due to increased demand. This shortage has forced some people taking Ozempic to suddenly stop, resulting in them gaining some or all of their weight back, as mentioned above. The shortage also means that people with type-2 diabetes who rely on Ozempic are now experiencing difficulty obtaining the drug.

Due to the shortage of Ozempic, demand for a generic version of the drug has also increased. Generic drugs are drugs that have the same active ingredient formula as a brand name drug. While there is no generic alternative of Ozempic currently available, the high demand for the drug will likely result in manufacturers creating a generic version in the future.

As the youngest of three brothers, Sam Pondrom, JD, learned early on how to work effectively as part of a team. After graduating from Oklahoma State, an intrinsic sense of curiosity and a keen eye for details led him to work as an accountant for two Engineering-News Record top 40 construction firms. It was there where he honed his ability to analyze complex issues and craft clear, concise answers. Pondrom utilizes these skills to work in partnership with ByrdAdatto clients to resolve their complex business and regulatory concerns in the most simple, straightforward ways.

A national business and health care law firm, ByrdAdatto helps business and health care professionals navigate the complicated maze of legal issues that come with owning a successful and compliant business. This includes making the law accessible and easy to understand through ongoing education, thought leadership and creative solutions that positively impact clients and their businesses. ByrdAdatto works to ensure the legal affairs of your business are in order, and finds creative solutions to optimize your business, mitigate risk, avoid future legal issues and achieve long-term goals.